Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

elafibranor

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Generic Name:
elafibranor
Project Status:
Active
Therapeutic Area:
Primary biliary cholangitis (PBC)
Manufacturer:
Ipsen Biopharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0865-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ipsen Biopharmaceuticals Canada Inc. requests that elafibranor be funded as per the anticipated Health Canada indication.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Elafibranor is anticipated to be approved by Health Canada for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open18-Oct-24
Call for patient/clinician input closed13-Dec-24
Submission received27-Nov-24
Submission accepted11-Dec-24
Review initiated12-Dec-24
Draft CADTH review report(s) provided to sponsor for comment06-Mar-25
Deadline for sponsors comments18-Mar-25
CADTH review report(s) and responses to comments provided to sponsor09-Apr-25
Expert committee meeting (initial)23-Apr-25
Draft recommendation issued to sponsorMay 05, 2025
To
May 07, 2025
Draft recommendation posted for stakeholder feedback15-May-25
End of feedback period30-May-25

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Patient and Clinician Group input View PDF
Last Updated : March 6, 2025